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Clinical Trials/ISRCTN42318360
ISRCTN42318360CompletedNot Applicable

The efficacy of the combination of allergen vaccination and vitamin D3 in the reduction of allergen-specific nasal responses. A placebo controlled trial.

Academic Medical Centre (AMC) (Netherlands)0 sites90 target enrollmentStarted: January 9, 2006Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
90
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •1. Patients with rhinoconjunctivitis with or without mild asthma for at least 2 years. Their allergic symptoms should be related to the grass-pollen season.
  • •2. A positive skin prick test for grass, minimally HEP 1
  • •3. Positive reaction to intranasal challenge with grass-pollen
  • •4. Age between 18 and 65
  • •5. Patients with a written informed consent
  • •Note: Patients with concomitant sensitisation to perennial allergens like house dust mite and pets can be included as long as they do not reveal clinical symptoms or only at very rare occasional exposure. In case of sensitisation to pets, these pets should not be present at home.

Exclusion Criteria

  • •1. Use of corticosteroids (systemic and local) outside grass-pollen season (May-July)
  • •2. Serious immunopathologic diseases or malignancies (including auto-immune diseases, tuberculosis)
  • •3. Severe asthma or emphysema, based on questionnaire; use of inhaled corticosteroids
  • •4. Chronic symptoms related to concomitant sensitisation to other perennial allergens like pets or mites
  • •5. Symptomatic coronary heart diseases or severe (even under treatment) arterial hypertension
  • •6. Diseases with a contra-indication for the use of adrenaline
  • •7. Severe kidney disease
  • •8. Treatment with beta-blockers or ACE inhibitors or immunosuppressive drugs
  • •9. Severe atopic dermatitis
  • •10. Immunotherapy (including sublingual) treatment with grass-pollen within the last 5 years
  • •11. Pregnancy, lactation or inadequate contraceptive measures
  • •12 Alcohol or drug abuse
  • •13. Lack of co-operation or severe psychological disorders

Investigators

Sponsor
Academic Medical Centre (AMC) (Netherlands)

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